MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CD004
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: gynecologic laparoscopic minimally invasive surgery.Event description: the complaint was generated from medwatch report # (b)(4) received 02may2025.I was told by rn scrub that a plastic piece on the tip of the 12/15 bag broke off inside of the trocar.The broken piece was retrieved (and remained in the trocar).The endo catch bag, broken piece, and corresponding wrapper was placed in a bag and given to materials management per the gyn slm [gynecologic laparoscopic minimally invasive surgery].Female, 48 yrs, black or african american.Event date: apr 2025.Additional information provided by {(b)(6)] on 20may2025): bag itself did not break.Plastic portion broken.All fragments were retrieved from the patient, nothing in patient.No bag did not burst.Additional information provided by [(b)(6)] on 20may2025: the trocar that was used with an inzii bag is not available for return.Intervention: all fragments were retrieved from the patient, patient status: no patient injury.Patient was discharged.
Event or Problem Description
Procedure performed: gynecologic laparoscopic minimally invasive surgery.Event description: the complaint was generated from medwatch report # (b)(4) received 02may2025.I was told by rn scrub that a plastic piece on the tip of the 12/15 bag broke off inside of the trocar.The broken piece was retrieved (and remained in the trocar).The endo catch bag, broken piece, and corresponding wrapper was placed in a bag and given to materials management per the gyn slm [gynecologic laparoscopic minimally invasive surgery].Female, 48 yrs, black or african american, event date: apr 2025.Additional information provided by [name] on 20may2025): bag itself did not break.Plastic portion broken.All fragments were retrieved from the patient, nothing in patient.No bag did not burst.Additional information provided by [name] on 20may2025: the trocar that was used with an inzii bag is not available for return.Intervention: all fragments were retrieved from the patient, patient status: no patient injury.Patient was discharged.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience component separation as the bead was detached from the bag.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant trends were identified.This report is to follow-up medwatch # (b)(4).

• Brand Name: INZII RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22074754
• Report Number: 2027111-2025-00547
• Device Sequence Number: 8397990
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPLIED TROCAR.
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Race: Black Or African American